BioNTech SE

BioNTech SE engages in the development of novel medicines at the intersection of immunology and synthetic biology. Its product pipeline include BNT162b2, BNT161, BNT164, FixVac, iNeST, RiboMabs, CAR-T Cells, TCRs and Next-Gen CP Immunomodulators. The company was founded by Christopher Huber, Ozlem Tureci and Ugur Sahin on June 2, 2008 and is headquartered in Mainz, Germany.

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BioNTech reports robust 2022 earnings, eyes growth in oncology and infectious diseases

BioNTech's strong financial performance in 2022 sets the stage for continued growth in 2023, with a focus on expanding its vaccine portfolio, advancing oncology programs, and navigating the evolving landscape of COVID-19. The company's strategic priorities align with market demands for infectious disease and oncology solutions, positioning BioNTech for future success and profitability.

BioNTech posts robust Q1 results, eyes growth in vaccines and oncology

BioNTech's Q1 2023 performance reflects strong financial results and promising developments in its vaccine and oncology programs.
While facing challenges such as seasonal trends and data constraints, the company is strategically positioned to leverage opportunities in commercial planning and therapeutic advancements.
With a focus on synergistic partnerships and innovative technologies, BioNTech aims to maintain its competitive edge in the biopharmaceutical industry.
The company's commitment to enhancing existing platforms and exploring new growth avenues underscores its resilience and adaptability in a dynamic market environment.

BioNTech reports mixed Q2 results, focuses on innovation and growth

BioNTech's Q2 2023 performance reflects a mix of strong revenue generation and financial challenges, emphasizing the importance of strategic focus.
The company's strengths lie in its innovative collaborations, pipeline advancements, and preparedness for market demands, despite facing financial losses.
Navigating challenges in financial sustainability, market competition, and stakeholder communication will be crucial for BioNTech's future growth and success.

BioNTech adjusts revenue guidance amidst vaccine demand challenges

BioNTech's Q3 2023 performance reflected revenue challenges from lower COVID-19 vaccine demand and write-downs, prompting revised revenue guidance.
Despite challenges, the company showcased strengths in vaccine development, oncology advancements, and strategic cost management initiatives.
Opportunities lie in shared R&D expenses, long-term growth prospects from combination vaccines, and maintaining financial strength during market transition.

BioNTech reports strong Q4 earnings, eyes diversified product expansion

BioNTech is strategically investing in expanding its product portfolio while navigating uncertainties in COVID-19 vaccine revenues. The company aims to transform into a multiproduct company by 2030, focusing on oncology and infectious diseases.

BioNTech advances oncology pipeline, eyes growth amid financial challenges

BioNTech is making significant strides in its oncology pipeline, aiming for multiple product launches by 2026 and focusing on cancer vaccines and mRNA treatments.
While facing financial losses and short-term profitability challenges, the company remains optimistic about its growth trajectory and revenue potential.
Strategic investments in technology platforms, commercial readiness, and partnerships position BioNTech for sustainable growth and value enhancement.
Balancing cost control, revenue generation, and clinical execution will be crucial for BioNTech to capitalize on opportunities and navigate challenges effectively.

BioNTech reports Q2 progress in oncology pipeline amid financial challenges

BioNTech's Q2 2024 earnings call highlighted progress in oncology and COVID-19 vaccines, with total revenues of EUR 129 million but a net loss of EUR 808 million. The company remains focused on advancing innovative therapies and expanding its global manufacturing capabilities.

BioNTech reports robust Q3 earnings, focuses on oncology pipeline

BioNTech's Q3 2024 performance was strong, driven by COVID-19 vaccines and oncology trials.
While facing revenue challenges in certain regions, the company remains focused on growth.
Opportunities lie in advancing oncology pipeline and demonstrating product potential.
Maintaining a strong cash position provides flexibility for future investments.

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BioNTech SE operates as immunotherapy company, which engages therapies for cancer and other serious diseases. Its product pipeline include BNT162b2, BNT161, BNT164, FixVac, iNeST, RiboMabs, CAR-T Cells, TCRs and Next-Gen CP Immunomodulators. The company was founded by Christopher Huber, Oezlem Tuereci, and Ugur Sahin on June 2, 2008 and is headquartered in Mainz, Germany.

Novavax

Comirnaty, the COVID-19 vaccine produced by Pfizer-BioNTech, has been recommended for children between 5 and 11 years old. The White House has acquired sufficient vaccines from Pfizer-BioNTech. It is targeted for distribution to more than 25,000 pediatricians' offices, hospitals, and pharmacies.

Novavax Is Finally Coming For BioNTech's Dominance

Pfizer

Pfizer Inc. PFE, +0.41% and German partner BioNTech SE BNTX, +0.27% said Thursday the U.S. government has purchased an additional 50 million pediatric doses of their COVID-19 vaccine, as it prepares to start dosing children. The additional order includes vaccines for children below the age of 5, assuming they will receive regulatory authorization.

Pfizer and BioNTech say U.S. government has purchased additional 50 million pediatric doses of their COVID vaccine

NEW YORK & MAINZ, Germany--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. government has purchased 50 million more doses of the companies' COVID-19 vaccine. The U.S. will receive these additional doses to continue to support preparedness for pediatric vaccinations, including securing vaccines for children under 5 years of age, should they receive regulatory authorization. The companies expect to deliver all these doses by April 30, 2022. Wi

Pfizer and BioNTech to Provide U.S. Government an Additional 50 Million Pediatric Doses of COVID-19 Vaccine to Support Further Preparedness for Future Needs

These are Insider's biggest healthcare stories for October 27.

The FDA's expert panel backs Pfizer's COVID-19 vaccines for younger kids

The FDA's Vaccines and Related Biological Products Advisory Committee voted 17-0 favor Pfizer Inc (NYSE: PFE) - BioNTech SE's (NASDAQ: BNTX) COVID-19 vaccine in younger children. With one panelist abstaining, the FDA Advisory Committee said that the vaccine outweighs the risks for children between five and 12.

FDA's Adcomm Almost Unanimously Back Pfizer/BioNTech's COVID-19 Shots For Younger Kids

Mainz, Germany, October 27, 2021 (GLOBE NEWSWIRE) – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will announce its financial results for the third quarter on Tuesday, November 9th, 2021. BioNTech invites investors and the general public to join a conference call and webcast with investment analysts on the same day at 8.00 a.m. ET (2.00 p.m. CET) to report its financial results and provide a corporate update for the third quarter 2021.

BioNTech to Report Third Quarter Financial Results and Operational Update on November 9, 2021

NEW YORK and MAINZ, GERMANY, OCTOBER 26, 2021 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 17 to 0, with 1 abstention, to recommend that the FDA grant Emergency Use Authorization (EUA) for the companies' COVID-19 vaccine in children 5 to

FDA Advisory Committee Votes in Favor of Granting Emergency Use Authorization for the Pfizer-BioNTech Covid-19 Vaccine in Children 5 to

BioNTech SE (NASDAQ: BNTX) said it had signed a Memorandum of Understanding with the Rwandan government and Institut Pasteur de Dakar in Senegal to construct the first mRNA vaccine manufacturing facility in Africa starting in mid-2022. BioNTech will initially build a production line with 50 million doses annual capacity, which could be used for COVID-19 vaccines.

BioNTech To Start Building mRNA Vaccine Facility In Africa In Mid-2022

A group of scientists who advise the Food and Drug Administration said the benefits of BioNTech BNTX, -0.86% and Pfizer's PFE, +0.95% COVID-19 vaccine outweigh the risks for children between the ages of 5 and 11.

FDA advisors recommend BioNTech and Pfizer's COVID-19 shot for children

Shares of BioNTech SE BNTX, +5.96% gained 0.7% in premarket trading on Tuesday after the company said it plans to start building a manufacturing facility for its mRNA vaccines in the African Union in 2022. Once completed, the site is expected to have the capacity to produce several hundreds of millions of doses of BioNTech's vaccines, including the ability to produce the products used to make 50 million COVID-19 vaccine doses per year.

BioNTech to build mRNA manufacturing facility in the African Union

MAINZ, Germany, October 26, 2021 — BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced that the Company plans to initiate the construction of the first state-of-the-art manufacturing site for mRNA-based vaccines in the African Union in mid-2022. This is the next step in BioNTech's efforts to implement sustainable end-to-end vaccine supply solutions on the African continent. The decision is the result of a meeting between Rwanda's Minister of Health, Dr Daniel M. Ngamije, Senegal's Minister of Foreign Affairs Aïssata Tall Sall, Ugur Sahin, M.D.,CEO and Co-Founder of BioNTech and Sierk Poetting, COO of BioNTech as well as Dr Sabin Nsanzimana, Director-General of Rwanda Biomedical Centre and Dr Amadou Alpha Sall, Directeur-General of Institut Pasteur de Dakar in Kigali, Rwanda. The meeting occurred upon the invitation of the kENUP Foundation and took place as a side-event of the Second Ministerial Meeting of the African Union and the European Union and resulted in a Memorandum of Understanding (MoU). This comes after the parties signed a Joint Communiqué at a previous meeting in Berlin on August 27, 2021.

BioNTech Plans to Initiate the Construction of an mRNA Vaccine Manufacturing Facility in Africa in mid-2022

The FDA's decision to allow mix-and-match boosters shakes up the COVID-19 vaccine market.

Why Pfizer and BioNTech Will Be Bigger Winners Than Moderna With Mix-and-Match Boosters

Apple

Alphabet

Kimberly-Clark

Moderna

Microsoft

Tech Giants to Report Earnings This Week

SPDR S&P 500 ETF Trust

The Dow is +25 points, the S&P 500 +5 and the tech-heavy Nasdaq, which houses the FAANG stocks, is +45 points at this hour.

Big Week for FAANG, Economic Reads

These are Insider's biggest healthcare stories for October 25.

The FDA is set to review Pfizer's coronavirus vaccine for kids 5- to 11-years old

A Food and Drug Administration advisory committee is set to meet Tuesday to discuss and then recommend whether the benefits outweigh the risks of BioNTech SE BNTX, -2.80% and Pfizer Inc.'s PFE, +0.70% COVID-19 vaccine in children between the ages of 5 and 11 years old. The FDA is not required to follow the advice of the committee but often does.

FDA committee to discuss BioNTech/Pfizer's COVID-19 shot in children 5 to 11

BioNTech founders were confident in the potential of their mRNA technology, which they knew could trigger a powerful immune response.

How BioNTech went from a little-known biotech company to creating the Covid vaccine

American Express

Snap

V.F.

Not only good Q3 numbers, but Covid vaccine news and hope for an infrastructure passage are keeping bullish sentiment in the market.

Reasons for Optimism: Q3 Earnings, Infrastructure

Kid-size doses of Pfizer's COVID-19 vaccine appear safe and nearly 91% effective at preventing symptomatic infections in 5- to 11-year-olds, according to study details released Friday as the U.S. considers opening vaccinations to that age group.

Pfizer says COVID-19 vaccine is more than 90% effective in 5- to 11-year-olds

The latest data comes as the FDA enters the final stages of reviewing Pfizer's application to offer its shot to 5- to 11-year-olds.

The Pfizer-BioNTech COVID-19 vaccine is 91% effective in 5- to 11-year-olds, new study results show

The drugmaker said its vaccine is highly effective at preventing against symptomatic infection for children between the ages of 5 and 11.

Pfizer Says Its Covid Vaccine Is 91% Effective At Preventing Infection For Young Kids

RedHill Biopharma

Why BioNTech and RedHill Are Soaring This Week, While Novavax Is Sinking

On the strength of the Covid-19 vaccine it co-developed with Pfizer Inc. ( PFE , Financial), BioNTech SE ( BNTX , Financial) shares rose about 200% in the past year, making it one of the top European biotech stocks cited by Labiotech.eu.

Shares of Covid-19 Vaccine Co-Developer BioNTech Have Soared Over Past Year

Pfizer Inc (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) announced topline results from a Phase 3 trial evaluating the efficacy and safety of a 30-µg booster dose of its COVID-19 vaccine. Related:   Pfizer/BioNTech COVID-19 Boosters For Seniors, Certain Vulnerable Adults Coming Soon - CDC Panel Recommends.

Pfizer-BioNTech's COVID-19 Booster Study Shows Robust Efficacy

BioNTech SE (NASDAQ: BNTX) shares rose on Thursday after the company and Pfizer Inc. (NYSE: PFE) announced that a booster shot of their COVID-19 vaccine was found to have a high efficacy of 95.6%. The companies stated that the vaccine booster's efficacy was strong for different demographic groups, "efficacy was consistent irrespective of age, sex, race, ethnicity or comorbid conditions.

News for BioNTech SE Stock (BNTX)